Zithromax Dosage

Generic name: azithromycin dihydrate
Dosage form: tablets and oral suspension

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)

Adults

Infection* Recommended Dose/Duration of Therapy
*
DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)
Community-aquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic
obstructive pulmonary disease (mild to moderate)
500 mg QD × 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis 500 mg QD × 3 days
Genital ulcer disease (chancroid) One single 1 gram dose
Non-gonoccocal urethritis and cervicitis One single 1 gram dose
Gonococcal urethritis and cervicitis One single 2 gram dose

ZITHROMAX tablets can be taken with or without food.

Renal Insufficiency

No dosage adjustment is recommended for subjects with renal impairment (GFR ≤80 mL/min). The mean AUC0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR <10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)

Hepatic Insufficiency

The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

Pediatric Patients

ZITHROMAX for oral suspension can be taken with or without food.

Acute Otitis Media

The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

Acute Bacterial Sinusitis

The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)

Community-Acquired Pneumonia

The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)


PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1 Days 2–5 Day 1 Days 2–5
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
5 11 2.5 mL
(½ tsp)
1.25 mL
(¼ tsp)
7.5 mL 150 mg
10 22 5 mL
(1 tsp)
2.5 mL
(½ tsp)
15 mL 300 mg
20 44 5 mL
(1 tsp)
2.5 mL
(½ tsp)
15 mL 600 mg
30 66 7.5 mL
(1½ tsp)
3.75 mL
(¾ tsp)
22.5 mL 900 mg
40 88 10 mL
(2 tsp)
5 mL
(1 tsp)
30 mL 1200 mg
50 and above 110 and above 12.5 mL
(2½ tsp)
6.25 mL
(1¼ tsp)
37.5 mL 1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day
Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1–3 Day 1–3
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
5 11 2.5 mL
(1/2 tsp)
7.5 mL 150 mg
10 22 5 mL
(1 tsp)
15 mL 300 mg
20 44 5 mL
(1 tsp)
15 mL 600 mg
30 66 7.5 mL
(1 ½ tsp)
22.5 mL 900 mg
40 88 10 mL
(2 tsp)
30 mL 1200 mg
50 and above 110 and above 12.5 mL
(2 ½ tsp)
37.5 mL 1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1
5 11 3.75 mL
(3/4 tsp)
3.75 mL
150 mg
10 22 7.5 mL
(1 ½ tsp)
7.5 mL 300 mg
20 44 15 mL
(3 tsp)
15 mL 600 mg
30 66 22.5 mL
(4 ½ tsp)
22.5 mL 900 mg
40 88 30 mL
(6 tsp)
30 mL 1200 mg
50 and above 110 and above 37.5 mL
(7 ½ tsp)
37.5 mL 1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis

The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)


PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS—Pediatric Use.) Based on Body Weight

PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1–5
8 18 2.5 mL
(½ tsp)
12.5 mL 500 mg
17 37 5 mL
(1 tsp)
25 mL 1000 mg
25 55 7.5 mL
(1½ tsp)
37.5 mL 1500 mg
33 73 10 mL
(2 tsp)
50 mL 2000 mg
40 88 12.5 mL
(2½ tsp)
62.5 mL 2500 mg

Constituting instructions for ZITHROMAX Oral Suspension, 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:

Amount of water to be added Total volume after constitution (azithromycin content) Azithromycin concentration after constitution
9 mL (300 mg) 15 mL (300 mg) 100 mg/5 mL
9 mL (600 mg) 15 mL (600 mg) 200 mg/5 mL
12 mL (900 mg) 22.5 mL (900 mg) 200 mg/5 mL
15 mL (1200 mg) 30 mL (1200 mg) 200 mg/5 mL

Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

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